An Open Randomised Trial of Zoladex versus CMF as Adjuvant Therapy in the Management of Node Positive Stage II Breast Cancer in Pre/Peri-Menopausal Women Aged 50 Years or Less

ISRCTN	ISRCTN15682734
DOI	https://doi.org/10.1186/ISRCTN15682734
Protocol serial number	ZEN2802
Sponsor	AstraZeneca Clinical Research Group (UK)
Funder	AstraZeneca Pharmaceuticals

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast
Intervention	Patients are randomised to one of two treatment arms: 1. Arm A: Zoladex, 3.6 mg given subcutaneously every 28 days for 2 years or until a treatment endpoint is reached. 2. Arm B: Chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 28 days for six cycles.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1996

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key inclusion criteria	1. Pre- or peri-menopausal 2. Node positive stage II breast cancer, at entry to study, consisting of: 2.1. Histologically proven operable invasive breast cancer 2.2. Pathologically involved lymph nodes c. No evidence of metastatic disease 3. No previous systemic therapy for breast cancer 4. Adequate hepatic, renal and haematological function 5. No bilateral oophorectomy or radiotherapy to the ovaries 6. No concurrent or previous malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1995
Date of final enrolment	31/12/1996

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/12/2002		Yes	No